This call focuses on the development of paediatric drug formulations for poverty-related diseases (RIA2019PD), is part of the European Development Clinical Trials Partnership (EDCTP).
Poverty-related diseases (PRDs) remain the leading causes of morbidity and mortality in sub-Saharan Africa, especially during childhood. Despite progress in other age groups, effective treatment and prevention of PRDs in paediatric populations is often lacking and/or lagging. The frequent exclusion of children and adolescents from clinical trials and the paucity of available products that target this group are factors that contribute to this population having one of the lowest health indicators. Additional challenges relate to the limited financial incentives associated with the adaption of off-patent medicines to the specific needs of paediatric populations. Therefore, concerted efforts are needed to increase access to potentially life-saving, cost-effective interventions to prevent and treat PRDs in children and to enhance the use of existing interventions in this population.
Proposals should focus on the adaptation of existing medicinal products (drugs), including off-patent products, to the specific needs of children (0-17 years of age). Proposals may address any of the PRDs within the remit of the EDCTP2 programme. Proposals should include one (or more) clinical trials conducted in sub-Saharan Africa to assess the safety, efficacy and pharmacokinetics of the drug(s), and/or the development of age-appropriate formulations. Projects must assure that the clinical trials are conducted appropriately, in line with guidelines on pharmaceutical development of medicines for paediatric use, respecting current legislation and considering the ethical aspects and particular needs of the study subjects and their families. Applicants should seek advice on the clinical trial design from the appropriate regulatory agency(ies) before developing the application. The EDCTP Association considers that proposals for actions of between 36 and 60 months duration would allow this specific challenge to be addressed appropriately.
The clinical need for paediatric dosing should be clearly explained in the proposal. The proposal must include full details of the strategy for the clinical paediatric development, including product development milestones and go/no-go criteria for the proposed clinical trial(s) as well as specific plans for the subsequent regulatory approval process, ideally a paediatric investigation plan, which should aim at obtaining a relevant market authorisation such as the Paediatric Use Marketing Authorisation (PUMA) or equivalent.
The actions supported under this call should have the potential to achieve maximum impact in the field and to make a significant contribution to the objectives of the EDCTP2 programme, and in particular:
- contribute towards the development or adaptation of medicinal products for use in children;
- lead to the advancement of new drugs and/or drug combinations, with the aim of registration of new drug(s) and/or drug combinations for treatment and prevention of PRDs in children in sub-Saharan Africa and globally;
- contribute to the reduction of mortality and morbidity in sub-Saharan Africa, particularly in children and thus contribute to achieving SDG 3 ‘Ensure healthy lives and promote well-being for all at all ages’.
10th of October 2019